BioHorizons TTLY3012Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Tissue Level Implant, 3.0 x 12mm, 3.5 platform · Class 2 · Implant
Quick summary
This BioHorizons tapered tissue-level implant is a root-form implant placed in bone to hold a replacement tooth. The 23 reports that name its identifier mostly describe implants that did not bond with the surrounding bone, including 22 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00847236009557), received between Feb 29, 2024 and Jun 16, 2026 — classified as 20 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, K223697); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate19
- Use of Device Problem2
Patient problems
- Insufficient Information21
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2026Failure to Osseointegrate
InjuryMay 21, 2026Failure to Osseointegrate
InjuryMay 21, 2026Failure to Osseointegrate
InjuryMay 21, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24601890 ↗InjuryFeb 23, 2026Failure to Osseointegrate
InjuryDec 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23812223 ↗InjuryOct 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionFeb 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, K223697. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2025 · Dec 6, 2024 · Open, ClassifiedTemporary Titanium Abutments
- Z-1605-2015 · Apr 16, 2015 · TerminatedTapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.